Low-Dose Dexmedetomidine for Postoperative Pain in Scoliosis

Overseen By Julia Leamon, MSN, RN, CPN

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Mercy Hospital Kansas City

Must not be taking: Opioids, TCA's, Gabapentinoids, Digoxin

Disqualifiers: Chronic pain, Unstable cardiac, Moya Moya, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 48

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a low dose of dexmedetomidine to the usual pain management plan can reduce the need for narcotics and lessen side effects after surgery in adolescents with idiopathic scoliosis. Idiopathic scoliosis causes the spine to curve sideways, and the surgery involves fusing parts of the spine. Participants must have idiopathic scoliosis and undergo a specific type of back surgery involving both the upper and lower spine. The study compares the effects of dexmedetomidine to a placebo (a harmless, inactive treatment) to determine its impact on pain management. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently taking opioids, TCAs (tricyclic antidepressants), or gabapentinoids for chronic pain, you would not be eligible to participate.

What is the safety track record for dexmedetomidine?

Research has shown that dexmedetomidine is generally safe for managing post-surgical pain. One study found that it helps stabilize vital signs and improves recovery for patients experiencing sudden pain after surgery. Another study suggested that dexmedetomidine is a safe addition to pain management after spinal fusion surgeries, effectively complementing other pain treatments without causing serious side effects.

While some studies report that dexmedetomidine does not reduce opioid use, it likely enhances overall recovery quality and reduces long-term post-surgical pain. Since the FDA has already approved this treatment for other uses, it is considered safe for humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dexmedetomidine is unique because it offers a new approach to managing postoperative pain in scoliosis patients. Unlike standard treatments like opioids and NSAIDs, which mainly block pain receptors and reduce inflammation, dexmedetomidine works by activating alpha-2 adrenergic receptors. This action can potentially reduce pain with fewer side effects, such as sedation or risk of addiction. Researchers are excited about dexmedetomidine because it could provide effective pain relief while minimizing the need for traditional painkillers, making recovery smoother and safer for patients.

What evidence suggests that low-dose dexmedetomidine might be an effective treatment for postoperative pain in scoliosis?

Research has shown that dexmedetomidine can reduce pain after surgery. For individuals undergoing orthopedic surgery, it improves pain control and decreases the need for opioid painkillers. In studies with children who have scoliosis, dexmedetomidine led to reduced opioid use post-surgery. It also enhances overall recovery and reduces long-term pain after surgery. In this trial, one group of participants will receive a low-dose dexmedetomidine infusion alongside the standard post-operative pain management protocol, while the control group will receive a normal saline infusion. These findings suggest that dexmedetomidine could be a valuable component of pain management for scoliosis surgery. ^{3 4 5 6 7}

Who Is on the Research Team?

Nichole M Doyle, MD

Principal Investigator

Children's Mercy Hospital Kansas City

Are You a Good Fit for This Trial?

This trial is for adolescents with idiopathic scoliosis who are having a spinal fusion surgery involving at least five levels of both thoracic and lumbar spine. It's not open to those who don't meet these specific surgical and diagnostic criteria.

Inclusion Criteria

I am having a spine surgery that involves both my upper and lower back.

I have been diagnosed with idiopathic scoliosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a low dose dexmedetomidine infusion or a normal saline infusion for 48 hours post-operatively

2 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and side effects

48 hours

Questionnaire every 48 hours

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine

Trial Overview The study is testing if low-dose dexmedetomidine added to standard pain management after surgery can reduce the need for narcotics and lessen side effects in teens with scoliosis undergoing spinal fusion.

How Is the Trial Designed?

Group I: Dexmedetomidine Experimental Treatment 1 Intervention

Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol

Group II: Control Placebo Group 1 Intervention

Patient receives normal saline infusion in addition to normal post-operative pain management protocol

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

A mini-dose combination of esketamine and dexmedetomidine significantly reduced the incidence of moderate-to-severe pain after scoliosis correction surgery, with 65.7% of patients experiencing pain compared to 86.0% in the placebo group.

Patients receiving the combination treatment also reported better sleep quality and lower pain intensity both at rest and during movement, without an increase in adverse events, indicating a safe and effective analgesic strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Zhang, Y., Cui, F., Ma, JH., et al.[2023]

In a case study of a 16-year-old girl undergoing scoliosis surgery, the use of dexmedetomidine in combination with total intravenous anesthesia provided effective sedation and analgesia during the critical wake-up test, allowing for safe assessment of lower limb movement.

The patient successfully regained spontaneous ventilation and was able to move her lower limbs upon command 14 minutes after the withdrawal of propofol and remifentanil, demonstrating the efficacy of dexmedetomidine in maintaining sedation while ensuring patient safety during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dexmedetomidine as adjuvant drug for wake-up test during scoliosis correction surgery: case report.]. Bagatini, A., Volquind, D., Rosso, A., et al.[2022]

Dexmedetomidine is gaining popularity in pediatric care due to its strong safety and efficacy profile, particularly as an alternative to morphine for pain management in surgeries like craniosynostosis repair.

This study is the first to specifically evaluate the use of dexmedetomidine as a postoperative analgesic and sedative in children after craniosynostosis repair, highlighting a gap in existing research on its application in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Precedex in Post-Operative Pain Management Following Craniosynostosis Repair. Xu, H., Bui, A., Brown, S., et al.[2021]

Dexmedetomidine is commonly used as a safe sedative during surgeries, but there are rare cases where it can lead to serious complications, such as cardiac arrest.

In this report, a 76-year-old woman experienced cardiac arrest during a pacemaker lead extraction procedure while being treated with dexmedetomidine, highlighting the need for careful monitoring in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. Shah, AN., Koneru, J., Nicoara, A., et al.[2013]

In a study of 60 ASA III patients undergoing spinal orthopedic scoliosis correction surgery, dexmedetomidine at doses of 0.2 to 0.3 μg/(kg·h) resulted in shorter wake-up times and fewer hemodynamic fluctuations compared to a higher dose of 0.4 μg/(kg·h).

Group B (0.3 μg/(kg·h)) showed significantly higher mean arterial pressure just before and at the moment of wake-up compared to Group A (0.2 μg/(kg·h)), indicating better hemodynamic stability with this dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine dosage in critically ill patients undergoing intraoperative wake-up test: A randomized controlled trial. Yang, T., Mudabbar, MS., Chen, T., et al.[2022]

In a study of 24 pediatric patients undergoing airway reconstruction, dexmedetomidine was found to be well tolerated and safe, particularly for short-term intubation, with no significant adverse effects reported.

Dexmedetomidine may serve as a beneficial alternative to propofol for sedation during the periextubation period, allowing for easily reversible sedation, although further research is needed to explore its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. Silver, AL., Yager, P., Purohit, P., et al.[2022]

In a study involving 91 pediatric patients, dexmedetomidine was found to be a well-tolerated alternative sedative for non-intubated moderate or deep sedation, with a low incidence of serious adverse events.

While respiratory depression and hypotension were the most common treatment-emergent adverse events, they were manageable and consistent with dexmedetomidine's known safety profile, indicating its potential for safe use in children during elective procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. Jooste, EH., Hammer, GB., Reyes, CR., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12165510/

Efficacy of perioperative dexmedetomidine in postoperative ... Our study demonstrates that intravenous dexmedetomidine significantly improved postoperative pain and neurocognitive functions in orthopedic surgery patients.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24743445/

Evaluation of dexmedetomidine and postoperative pain ... This study evaluated the effectiveness of dexmedetomidine in decreasing opioid use in children with adolescent idiopathic scoliosis following posterior spinal ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224003465

Effectiveness of dexmedetomidine on patient-centred ... Intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain after surgery.

4. clinicalpainadvisor.com clinicalpainadvisor.com/news/dexmedetomidine-provides-superior-analgesia-to-magnesium-in-scoliosis-surgery/

Dexmedetomidine Provides Superior Analgesia to ... The primary outcome was time to first postoperative morphine request; secondary outcomes included 48-hour morphine use, NRS pain scores at rest ...

5. journals.lww.com journals.lww.com/spinejournal/fulltext/2025/09150/effects_of_perineural_dexamethasone_and.1.aspx

Effects of Perineural Dexamethasone ... The primary outcome was time to first opioid analgesia. Secondary outcomes included total opioid consumption, postoperative pain scores, MEP amplitude and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12240532/

A randomized controlled clinical trial to investigate the efficacy ... Conclusions: Dexmedetomidine could effectively manage the vital signs of patients with postoperative acute pain, improve treatment outcomes, ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/15360288.2025.2548903?src=exp-la

Safety and Efficacy of Dexmedetomidine in Spinal Fusion Heterogeneity for opioid-related outcomes was high (I²=96%). In summary, DEX appears to be a safe adjunct for postoperative analgesia after spinal fusion, with ...